Sirocco

CompletedPhase 2

Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease

A Multi-centre, Double-blind, Double-dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease

Lead sponsor

AstraZeneca

Assets

AZD3480 / Donepezil

Listed sites

Recruiting sites

Enrollment

659

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD3690C00010

SecondaryEuDract 2007-00835-24

NCT IDNCT00501111

Timeline

Milestones

Study start2007-07 (month precision)

Study first posted2007-07-13estimated

Primary completion2008-08actual (month precision)

Study completion2008-08actual (month precision)

Last update posted2014-07-23estimated

Assets

Drug assets

AZD3480 Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Provision of informed consent from patient and caregiver

•Clinical prognosis of probable Alzheimer's disease

•Patient must have a caregiver visiting the patient at least three times weekly

Exclusion criteria

•Significant neurologic disease or dementia other than Alzheimer's disease

•Major depressive disorder, other major psychiatric disorder

•Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment

•Impaired vision and/or hearing making cognitive testing difficult

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

2 endpoints

Primary/protocol endpoint

Change in ADAS-Cog

Time frame:assessed after 12 weeks treatment

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE

Time frame:assessed after 12 weeks treatment

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.